PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS

K060645 · Roche Diagnostics Corp. · DKB · May 30, 2006 · Clinical Toxicology

Device Facts

• Record ID: K060645
• Device Name: PRECISET DAT PLUS I, PRECISET DAT PLUS II AND CFAS DAT QUALITATIVE PLUS CALIBRATORS
• Applicant: Roche Diagnostics Corp.
• Product Code: DKB · Clinical Toxicology
• Decision Date: May 30, 2006
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 862.3200
• Device Class: Class 2

Intended Use

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Device Story

Preciset DAT Plus I, Plus II, and Cfas DAT Qualitative Plus are multi-analyte calibrators; consist of drug/metabolite mixtures added to drug-free human urine with preservatives. Preciset DAT Plus I/II provide up to six concentration levels for quantitative calibration; Cfas DAT Qualitative Plus provides single-level calibration. Used in clinical laboratories on automated chemistry analyzers; operated by laboratory technicians. Calibrators establish reference points for Roche drugs of abuse assays; enable accurate quantification or qualitative detection of drugs (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, methaqualone, opiates, phencyclidine, propoxyphene) in patient urine. Results assist healthcare providers in toxicology screening and clinical decision-making regarding substance use.

Clinical Evidence

No clinical data. Bench testing only. Analyte concentrations are traceable to and verified by GC-MS primary reference methods.

Technological Characteristics

Multi-analyte calibrators; matrix is drug-free human urine with added preservatives/stabilizers. Form factor: liquid in bottles (up to 6 levels for quantitative, single level for qualitative). No energy source, connectivity, or software algorithms; purely chemical/biological reference material.

Indications for Use

Indicated for calibration of Roche drugs of abuse assays in human urine using automated clinical chemistry analyzers. Prescription use only.

Regulatory Classification

Identification

A clinical toxicology calibrator is a device intended for medical purposes for use in a test system to establish points of reference that are used in the determination of values in the measurement of substances in human specimens. A clinical toxicology calibrator can be a mixture of drugs or a specific material for a particular drug (e.g., ethanol, lidocaine, etc.). (See also § 862.2 in this part.)

Special Controls

*Classification.* Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 862.9.

Predicate Devices

• Preciset DAT Plus I calibrators (K031775)
• Preciset DAT Plus II and Cfas DAT Qualitative Plus (K033306)

Submission Summary (Full Text)

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# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY ASSAY ONLY TEMPLATE

A. 510(k) Number:
k060645

B. Purpose for Submission:
New document

C. Measurand:
The Roche Preciset DAT Plus I and Roche Cfas DAT Qualitative Plus - calibrators for amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, Methaqualone, opiates, phencyclidine and propoxyphene.

The Roche Preciset DAT Plus II - calibrator for amphetamines, benzodiazepines, cannabinoids and opiates.

D. Type of Test:
Not Applicable

E. Applicant:
Roche Diagnostics Corp.

F. Proprietary and Established Names:
Preciset DAT Plus I, Preciset DAT Plus II, and CFAS DAT Qualitative Plus Calibrators

G. Regulatory Information:

| Product Code | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| Calibrators, Drug Mixture (DKB) | Class II | 21 CFR 862.3200, Clinical toxicology calibrator. | 91 CLINICAL TOXICOLOGY (TX) |

H. Intended Use:
1. Intended use(s):

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See below indication(s) for use.

2. **Indication(s) for use:**

The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

3. **Special conditions for use statement(s):**

Prescription use.

4. **Special instrument requirements:**

Roche/Hitachi 911/912/917/MODULAR P analyzers

COBAS Integra 400/400plus/700/800

I. **Device Description:**

Roche Preciset DAT Plus I calibrators contain a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, methadone, methaqualone, opiates, phencyclidine, and propoxyphene. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective target levels are as follows:

- Amphetamines: 0, 250, 500, 1000, 3000, 5000 (ng/mL)
- Barbiturates: 0, 100, 200, 400 (ng/mL) [no 5th and 6th level]
- Benzodiazepines: 0, 150, 300, 600, 1000, 3000 (ng/mL)
- Cannabinoids: 0, 20, 50, 100, 200, 300 (ng/mL)
- Cocaine: 0, 75, 150, 300, 1000, 5000 (ng/mL)
- Methadone: 0, 150, 300, 600, 2000 (ng/mL) [no 6th level]
- Methaqualone: 0, 150, 300, 600 (ng/mL) [no 5th and 6th level]
- Opiates: 0, 600, 1000, 2000, 4000, 8000 (ng/mL)
- PCP: 0, 12.5, 25.0, 50.0 (ng/mL) [no 5th and 6th level]

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Propoxyphene: 0, 150, 300, 600 (ng/mL) [no 5th and 6th level]

Roche Preciset DAT Plus II calibrators contain a mixture of 4 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, benzodiazepines, cannabinoids, and opiates. The calibrator set contains up to six levels for each drug contained in bottles 1-6. Bottle 1 is negative (drug free) human urine, followed by bottles 2-6 containing increasing amounts of each drug in a multi-analyte mixture. Drug or drug metabolite and their respective target levels are as follows:

- Amphetamines: 0, 150, 300, 600, 1000, 2000 (ng/mL)
- Benzodiazepines: 0, 50, 100, 200, 400, 1000 (ng/mL)
- Cannabinoids: 0, 10, 20, 40, 100 (ng/mL) [no 6th level]
- Opiates: 0, 150, 300, 600, 1000, 2000 (ng/mL)

Roche Cfas DAT Qualitative Plus calibrator contains a mixture of 10 different drugs, prepared by quantitative addition of drug or drug metabolite to drug-free human urine. Drugs included are amphetamines, barbiturates, benzodiazepines, cannabinoids, methadone, Methaqualone, opiates, phencyclidine and propoxyphene. The calibrator set contains a single level for each drug in a drug mixture. Drugs or drug metabolites and their respective target levels are as follows:

- Amphetamines: 500 (ng/mL)
- Barbiturates: 200 (ng/mL)
- Benzodiazepines: 300 (ng/mL)
- Cannabinoids: 50 (ng/mL)
- Cocaine: 150 (ng/mL)
- Methadone: 300 (ng/mL)
- Methaqualone: 50 (ng/mL)
- Opiates: 2000 (ng/mL)
- Phencyclidine: 25 (ng/mL)
- Propoxyphene: 300 (ng/mL)

J. Substantial Equivalence Information:

| Predicate | k031775 - Preciset DAT Plus I
k033306: Preciset DAT Plus II and Cfas DAT Qualitative Plus |
| --- | --- |
| Describe the item being compared | |
| The Roche Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus multianalyte calibrators are substantially equivalent to the currently marketed Roche Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus multianalyte calibrators, manufactured for Roche Diagnostics and cleared in the following 510(k) submissions: K031775: Preciset DAT Plus I K033306: Preciset DAT Plus II and Cfas DAT Qualitative Plus. The Preciset DAT Plus I and Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | |

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| Similarities | | |
| --- | --- | --- |
| Feature | Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators (Predicate Device) | Roche Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrator |
| Indications for Use | Preciset DAT Plus I
The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Preciset DAT Plus II
The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Cfas DAT Qualitative Plus
The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. | Preciset DAT Plus I
The Preciset DAT Plus I calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Preciset DAT Plus II
The Preciset DAT Plus II calibrators are designed for the calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers.

Cfas DAT Qualitative Plus
The Cfas DAT Qualitative Plus calibrator is designed for the qualitative calibration of the Roche assays for drugs of abuse in human urine on automated clinical chemistry analyzers. |
| Type of Material | Preciset Dat Plus I
Liquid, ready to use calibrators, consists of 6 levels, Calibrators 1-6.

Cfas DAT Qualitative Plus
Liquid, ready to use calibrator, consists of a single level. | Preciset DAT Plus I
Liquid, ready to use calibrators, consists of 6 levels, Calibrators 1-6.

Cfas DAT Qualitative Plus
Liquid, ready to use calibrator, consists of a single level. |
| Matrix | Human urine with stabilizers and preservatives. | Human urine with stabilizers and preservatives. |
| Packaging | Preciset DAT Plus I
Calibrators 1-6: 5 ml each level

Preciset DAT Plus II
Calibrators 1-6 5 ml each level | Preciset DAT Plus I
Calibrators 1-6: 5 ml each level

Preciset DAT Plus II
Calibrators 1-6: 5 ml each level |

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| | Cfas DAT Qualitative Plus
Calibrator: 6 x 5 ml | Cfas DAT Qualitative Plus
Calibrator: 6 x 5 ml |
| --- | --- | --- |
| Differences | | |
| Feature | Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators (Predicate Device) | Roche Preciset DAT Plus I, Preciset DAT Plus II and Cfas DAT Qualitative Plus Calibrators |
| Calibrator Level | Preciset DAT Plus I | Preciset DAT Plus I |
| | Amphetamines (d-methamphetamine): 0, 250, 500, 1000, 3000, 5000 (ng/mL) | Amphetamines (d-methamphetamine): 0, 250, 500, 1000, 3000, 5000 (ng/mL) |
| | Barbiturates (Secobarbital): 0, 100, 200, 400 (ng/mL) | Barbiturates (Secobarbital): 0, 100, 200, 400 (ng/mL) |
| | Benzodiazepines (nordiazepam): 0, 150, 300, 600 (ng/mL) | Benzodiazepines (nordiazepam): 0, 150, 300, 600, 1000, 3000 (ng/mL) |
| | Cannabinoids (.9 TCH-COOH): 0, 20, 50, 100, 200, 300 (ng/mL) | Cannabinoids (.9 TCH-COOH): 0, 20, 50, 100, 200, 300 (ng/mL) |
| | Cocaine (benzoylecogonine): 0, 75, 150, 300, 1000, 5000 (ng/mL) | Cocaine (benzoylecogonine): 0, 75, 150, 300, 1000, 5000 (ng/mL) |
| | Methadone (dl-methadone): 0, 150, 300, 600, 2000 (ng/mL) | Methadone (dl-methadone): 0, 150, 300, 600, 2000 (ng/mL) |
| | Opiates (d-morhpine): 0, 600, 1000, 2000, 4000, 8000 (ng/mL) | Methaqualone (Methaqualone): 0, 150, 300, 600 (ng/mL) |
| | PCP (phencyclidine): 0, 12.5, 25.0, 50.0 (ng/mL) | Opiates (d-morhpine): 0, 600, 1000, 2000, 4000, 8000 (ng/mL) |
| | Propoxyphene (propoxyphene): 0, 150, 300, 600 ng/mL | PCP (phencyclidine): 0, 12.5, 25.0, 50.0 (ng/mL) |
| | | Propoxyphene (propoxyphene): 0, 150, 300, 600 ng/mL |
| | Preciset DAT Plus II | Preciset DAT Plus II |
| | Benzodiazepine: (nordiazepam): 0, 50, 100, 200, 400 ng/mL) no level 6 | Amphetamines (d-methamphetamine): 0, 150, 300, 600, 1000, 2000 (ng/mL) |

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| Opiates (d-morphine): 0, 150, 300, 600, 1000, 2000 (ng/mL) | Benzodiazepine: (nordiazepam): 0, 50, 100, 200, 400, 1000 ng/mL)
Cannabinoids (.9 THC-COOH): 0, 10, 20, 40, 100 (ng/mL)
Opiates (d-morphine): 0, 150, 300, 600, 1000, 2000 (ng/mL) |
| --- | --- |
| Cfas DAT Qualitative Plus | Cfas DAT Qualitative Plus |
| Barbiturates: 200 (ng/mL) | Amphetamines: 500 (ng/mL) |
| Benzodiazepines: 300 (ng/mL) | Barbiturates: 200 (ng/mL) |
| Cocaine: 150 (ng/mL) | Benzodiazepines: 300 (ng/mL) |
| Methadone: 300 (ng/mL) | Cannabinoids: 50 (ng/mL) |
| Opiates: 2000 (ng/mL) | Cocaine: 150 (ng/mL) |
| Phencyclidine: 25 (ng/mL) | Methadone: 300 (ng/mL) |
| Propoxyphene: 300 (ng/mL) | Methaqualone: 50 (ng/mL)
Opiates: 2000 (ng/mL)
Phencyclidine: 25 (ng/mL)
Propoxyphene: 300 (ng/mL) |

K. Standard/Guidance Document Referenced (if applicable):

STANDARDS

Title and Reference Number

Medical devices - Application of risk management to medical devices (14971:2000)

GUIDANCE

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| Document Title | Office | Division | Web Page |
| --- | --- | --- | --- |
| Guidance for Industry - Abbreviated 510(k) Submissions for In Vitro Diagnostic Calibrators; Final | OIVD | | http://www.fda.gov/cdrh/ode/calibrator.html |

L. Test Principle:
Not applicable

M. Performance Characteristics (if/when applicable):

1. Analytical performance:
a. Precision/Reproducibility:
Not applicable
b. Linearity/assay reportable range:
Not applicable
c. Traceability, Stability, Expected values (controls, calibrators, or methods):
Analyte concentrations in the Preciset DAT Plus I, Preciset DAT plus II and Cfas DAT Qualitative Plus calibrator sets are traceable to and verified by a primary reference method, specifically GC-MS.
d. Detection limit:
Not applicable
e. Analytical specificity:
Not applicable
f. Assay cut-off:
Not applicable

2. Comparison studies:
a. Method comparison with predicate device:

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Not applicable

b. Matrix comparison:

Not applicable

3. Clinical studies:

a. Clinical Sensitivity:

Not applicable

b. Clinical specificity:

Not applicable

c. Other clinical supportive data (when a. and b. are not applicable):

4. Clinical cut-off:

Not applicable

5. Expected values/Reference range:

Not applicable

N. Proposed Labeling:

The labeling is sufficient and it satisfies the requirements of 21 CFR Part 809.10.

O. Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.